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A Study to Address Precision and Refractive Predictability of Femtosecond Laser-assisted Astigmatic Keratotomy Following the Cataract Surgery

Astigmatism Clinical Trial

Official title:
A Single Centre Study to Address Precision and Refractive Predictability of Femtosecond Laser-assisted Astigmatic Keratotomy Following the Cataract Surgery

Clinical Trial Summary

The purpose of this open, prospective study is to address the effectiveness and precision of the VICTUS™ Femtosecond Laser Platform-assisted astigmatic keratotomy after femtolaser-assisted cataract surgery.

Clinical Trial Description

Corneal astigmatism after cataract surgery represents a considerable obstacle in the visual rehabilitation of patients. Up-to-date astigmatic keratotomy represents a standardized and effective procedure that allows decreasing of naturally occurring and surgically induced astigmatism. The shape and architecture of the Arcuate Incisions are pre-calculated based on a particular chosen nomogram. The different parameters of the Arcuate Incisions as radius, opening and position angle and cutting depth can be achieved precisely by the laser technology.

The laser-assisted Cataract surgery and the Arcuate Incisions are performed by means of a femtosecond laser (VICTUS™ FEMTOSECOND LASER PLATFORM®, Technolas Perfect Vision GmbH, Munich, Germany) which is in the presented study under investigation and is already CE-approved.

For this open, prospective data collection several selection criteria have been defined in order to obtain a data set of minimal 43 eyes and maximal 50 eyes. Depending on whether they will be treated unilateral or bilateral the number of subjects enrolled within this study sums up to 22-50 patients. The data is gathered in the Castrop-Rauxel Augenklinik and only from one experienced surgeon. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01752218
Study type Interventional
Source Technolas Perfect Vision GmbH
Contact
Status Completed
Phase N/A
Start date January 2013
Completion date April 2014
View Details
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